NALTREXONE HYDROCHLORIDE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NALTREXONE HYDROCHLORIDE (UNII: Z6375YW9SF) (NALTREXONE - UNII:5S6W795CQM)

Available from:

Bryant Ranch Prepack

INN (International Name):

NALTREXONE HYDROCHLORIDE

Composition:

NALTREXONE HYDROCHLORIDE 50 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NALTREXONE HYDROCHLORIDE- NALTREXONE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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NALTREXONE HYDROCHLORIDE TABLETS USP
50 MG
OPIOID ANTAGONIST
0902
RX ONLY
DESCRIPTION
Naltrexone Hydrochloride Tablets USP, an opioid antagonist, are a
synthetic congener of oxymorphone
with no opioid agonist properties. Naltrexone differs in structure
from oxymorphone in that the methyl
group on the nitrogen atom is replaced by a cyclopropylmethyl group.
Naltrexone Hydrochloride
Tablets USP are also related to the potent opioid antagonist,
naloxone, or n-allylnoroxymorphone. The
chemical name for naltrexone hydrochloride is Morphinan-6-one,
17-(cyclopropylmethyl)-4,5-epoxy-
3,14-dihydroxy-, hydrochloride, (5α)-.
C
H NO •HCL M.W. 377.86
Naltrexone Hydrochloride Tablets USP are a white, crystalline
compound. The hydrochloride salt is
soluble in water to the extent of about 100 mg/mL. Naltrexone
Hydrochloride Tablets USP are
available in scored film-coated tablets containing 50 mg of naltrexone
hydrochloride. Naltrexone
Hydrochloride Tablets USP also contain: colloidal silicon dioxide,
crospovidone, hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 80, red iron oxide, yellow iron oxide and titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Naltrexone hydrochloride is a pure opioid antagonist. It markedly
attenuates or completely blocks,
reversibly, the subjective effects of intravenously administered
opioids.
When coadministered with morphine, on a chronic basis, naltrexone
hydrochloride blocks the physical
dependence to morphine, heroin and other opioids.
Naltrexone hydrochloride has few, if any, intrinsic actions besides
its opioid blocking properties.
However, it does produce some pupillary constriction, by an unknown
mechanism.
20
23
4
The administration of naltrexone hydrochloride is not associated with
the development of tolerance or
dependence. In subjects physically dependent on opioids, naltrexone
hydrochlor